Transforming Clinical Trials: How Digital Endpoints Are Leading the Way

In the third episode of season 2, host Sabine Hutchison, Seuss+ CEO and Co-Founder, is joined  by Victoria Bangieva from the Digital Medicine Society (DiMe) and our very own Director of Digital Innovation, Lauren Alani

Together they explore the transformative potential of digital endpoints in clinical trials, emphasizing their role in revolutionizing data collection for patients, regulators, and payers. Despite the FDA’s recent qualification of the first digital endpoint, widespread adoption faces hurdles like unclear benefits, lack of use cases, and implementation complexities.

The Digital Medicine Society (DiMe) addresses these challenges through the “Building the Business Case for Digital Endpoints” initiative. This collaborative effort, involving nearly 40 organizations, aims to develop a framework to demonstrate the value of digital endpoints, aligning them with business goals and industry standards. The initiative provides open-source resources to encourage adoption and showcase the tangible benefits of digital strategies.

The episode features insights from Victoria Bangieva of DiMe and Lauren Alani of Seuss+, who discuss operational challenges and validation hurdles in deploying digital endpoints. They emphasize the importance of collaboration, robust validation, and a research-driven approach to implementation.  

Victoria Bangieva Bio

Victoria Bangieva, PhD is a licensed clinical psychologist who works at the intersection of clinical science, technology, and advocacy to advance clinical research and healthcare through the integration of digital health solutions. Dr. Bangieva has over 8 years of experience in the digital health industry designing, developing, and disseminating digital measures and therapeutics. Through these efforts, Dr. Bangieva is dedicated to increasing adoption of digital health solutions in routine care and clinical research.

Lauren Alani Bio

After receiving a BSc in medical microbiology and immunology, Lauren spent 14 years in business development (across pharma, medical devices, and life sciences software), where she acquired a healthy understanding of the challenges organizations face when facilitating efficient, effective, and engaging clinical trials.

Over the last five years, Lauren has focused on how advances in digital innovation can help mitigate risk and enhance the likelihood of success of trials, bridging the gap between trial requirements and the value delivered by clinical technology. During this time she also chaired the eDigital thought-leadership group for ACDM (Association of Clinical Data Management) in addition to volunteering as Head of the Intelligence Unit for HBA (Health Businesswomen’s Association).